Influenze of Glenosphere Size in Scapular Notch Development. Randomized Study Comparing 42 to 38 ECC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 主要终点
- scapular notch development
研究概览
简要总结
Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase. To improve that situation, eccentricity has been added to some glenospheres to increase glenoid overhanging. The objective is to assess if eccentricity can avoid scapular notch as effectively as bigger glenospheres.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
blinded to purpose of study and to randomization
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing reverse shoulder prosthesis because of rotator cuff disordes andacute fractures
排除标准
- •patients with previous surgery
- •patients with deltoid deficiency
- •patients with acute infection
研究组 & 干预措施
glenosphere 42
patients receiving a reverse shoulder arthroplasty with a glenosphere sized 42. reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch
干预措施: reverse shoulder arthroplasty (Device)
glenosphere 38 ECC
patients receiving a reverse shoulder arthroplasty with a glenosphere sized 38 ECC reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch
干预措施: reverse shoulder arthroplasty (Device)
结局指标
主要结局
scapular notch development
时间窗: two years
X-ray assessment of scapular notch development
次要结局
未报告次要终点
研究者
Carlos Torrens
Head of Shoulder Unit
Hospital del Mar